U.S. patent number 5,329,976 [Application Number 07/948,278] was granted by the patent office on 1994-07-19 for syringe-filling and medication mixing dispenser.
This patent grant is currently assigned to Habley Medical Technology Corporation. Invention is credited to Clark B. Foster, Terry M. Haber, William H. Smedley.
United States Patent |
5,329,976 |
Haber , et al. |
July 19, 1994 |
Syringe-filling and medication mixing dispenser
Abstract
A medication dispenser (2, 120) is used to directly fill a
syringe (8, 134) with measured amounts of one or more liquid
medications, typically two different types of insulin, from
containers, such as vials (4, 6) and cartridges (230, 232, 234)
each having a septum at one end; each cartridge has a pierceable
piston (256) at the other end. The septum of each container is
pierced by hollow liquid spikes (54) while hollow gas spikes (56)
pierce the septum of the vial and the piston of the cartridge.
Liquid is pumped out of the container and air is replaced into the
container through the liquid and gas spikes. Two of the cartridges
can contain a diluent (231) and a lyophilized component (233)
respectively; the diluent in the first cartridge can be pumped into
the second cartridge through a one-way valve to create a mixed
pharmaceutical which is then pumped into the syringe, with or
without another pharmaceutical.
Inventors: |
Haber; Terry M. (Lake Forest,
CA), Smedley; William H. (Lake Elsinore, CA), Foster;
Clark B. (Laguna Niguel, CA) |
Assignee: |
Habley Medical Technology
Corporation (Laguna Hills, CA)
|
Family
ID: |
27122790 |
Appl.
No.: |
07/948,278 |
Filed: |
September 21, 1992 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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805503 |
Dec 9, 1991 |
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Current U.S.
Class: |
141/25; 141/18;
141/309; 141/329; 141/35; 604/191; 604/407; 604/411 |
Current CPC
Class: |
A61J
1/2089 (20130101); A61J 1/2096 (20130101); A61J
1/201 (20150501); A61J 1/2017 (20150501); A61J
1/2055 (20150501); A61J 1/2065 (20150501); A61J
1/2075 (20150501); A61J 1/2082 (20150501); A61J
1/2058 (20150501) |
Current International
Class: |
A61J
1/00 (20060101); A61M 001/00 () |
Field of
Search: |
;141/18,21,25-27,29,46,285,309,59,35,104-106,329,330,375
;604/82,86,87,205,207-211,232,407,411-415,134-136,139,191
;222/135-137 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Jacyna; J. Casimer
Attorney, Agent or Firm: Townsend & Townsend Khourie
& Crew
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This is a continuation-in-part of U.S. patent application Ser. No.
07/805,503 filed Dec. 9, 1991 for Syringe-Filling Medication
Dispenser, the disclosure of which is incorporated by reference.
This is also related to U.S. Pat. application Ser. No. 07/667,319
filed Mar. 8, 1991 for Multiple Cartridge Syringe; and U.S. patent
application Ser. No. 07/668,278 filed Mar. 8, 1991 for
Multipharmaceutical Syringe, all assigned to the assignee of the
present invention, the disclosures of which are incorporated by
reference.
Claims
What is claimed is:
1. A multiple medication dispenser, for use with first and second
containers containing first and second liquid medications and a
syringe of the type including a needle cannula, a barrel and a
plunger, the dispenser comprising:
a body to which the first and second containers and the syringe are
mountable;
first and second dual port means for providing first and second gas
and liquid ports into the interiors of the first and second
containers;
first means for substantially simultaneously pumping a first gas
into the first container through the first gas port and the first
liquid medication from the first container through the first liquid
port;
second means for substantially simultaneously pumping a second gas
into the second container through the second gas port and the
second liquid medication from the second container through the
second liquid port;
means for fluidly directing the first and second liquid medications
from the first and second pumping means to the needle cannula;
whereby the first and second liquid medications are pumped from the
first and second containers by the first and second pumping means,
through the needle cannula and into the syringe.
2. A medication dispenser, for use with a first container
containing a first, liquid pharmaceutical, a second container
containing a second pharmaceutical and a syringe of the type
including a needle cannula, a barrel and a plunger, the dispenser
comprising:
a body to which the containers and the syringe are mountable;
dual port means for providing first and second gas and liquid ports
into the interiors of the first and second containers;
a first passageway fluidly connecting the first and second liquid
ports to permit fluid flow from the first container to the second
container but not flow in the reverse direction;
first means for pumping the first liquid pharmaceutical into the
second container through the first and second liquid ports along
the first passageway so the pumped first pharmaceutical mixes with
the second pharmaceutical in the second container to create a first
mixed liquid pharmaceutical while gasses pass into the first
container and out of the second container through the first and
second gas ports, respectively;
second means for pumping the first mixed liquid pharmaceutical from
the second container through the second liquid port while replacing
the first mixed pharmaceutical with gas which passes into the
second container through the second gas port; and
means for fluidly directing the first mixed pharmaceutical from the
second liquid port to the needle cannula;
whereby the mixed pharmaceutical is pumped from the second
container by the second pumping means, through the needle cannula
and into the syringe.
3. The dispenser of claim 2 wherein the body includes cavities for
housing the container and the syringe.
4. The dispenser of claim 2 wherein the dual port means includes a
septum-pierceable, hollow liquid spike and a piston-pierceable,
hollow gas spike.
5. The dispenser of claim 2 further comprising means for visually
indicating the amount of the mixed pharmaceutical pumped into the
syringe.
6. The dispenser of claim 5 wherein the first and second pumping
means include means for preventing the pumping of liquid from the
second container into the first container.
7. The dispenser of claim 2 wherein the fluidly directly means
includes a septum mounted to the body and pierceable by the needle
cannula.
8. The dispenser of claim 2 further comprising a gas filter coupled
to the gas port.
9. The dispenser of claim 8 wherein the gas filter is coupled to
the ambient atmosphere.
10. The dispenser of claim 2 wherein the first pumping means
includes a piston and cylinder assembly.
11. The dispenser of claim 10 wherein the first pumping means is
actuated by reciprocal movement of the first container.
12. The dispenser of claim 11 wherein the piston and cylinder
assembly includes a cylinder and a piston, coupled to the first
container, for reciprocal movement with the first container within
the cylinder between a delivery position and a replenish position,
the cylinder having a cylinder wall.
13. The dispenser of claim 12 wherein the first pumping means
includes a check valve fluidly coupling the container and the
cylinder.
14. The dispenser of claim 13 wherein:
the check valve includes a flapper element which frictionally
engages the cylinder wall as the piston moves between the distal
position and the proximal position;
the friction between the cylinder wall and the flapper element
being sufficient and the flapper element constructed to cause the
flapper element to seal the cylinder from the container and to
fluidly couple the cylinder to the container when the piston moves
towards the delivery position and towards the replenish position,
respectively.
15. The dispenser of claim 2 wherein the fluidly directing means
includes supplemental check valves which permit fluid flow from the
second liquid port to the needle cannula but prevents fluid flow
from the needle cannula to the second liquid port.
16. The dispenser of claim 2 wherein the fluidly directing means
includes a resilient pathway element having a flow surface which
can deflect according to a fluid pressure applied thereto.
17. The dispenser of claim 16 wherein the resilient pathway element
includes an elastomeric material supported on a support surface
containing a groove, the elastomeric material being deflectable
into the groove thereby deflecting the flow surface.
18. The dispenser of claim 2 wherein the fluidly directing means
includes accumulator means for providing a pressurized liquid
accumulation region to accommodate any flow restriction created by
the needle cannula.
19. A medication dispenser, for use with a first container
containing a first, liquid pharmaceutical, a second container
containing a second pharmaceutical, a third container containing a
third, liquid pharmaceutical and a syringe of the type including a
needle cannula, a barrel and a plunger, the dispenser
comprising:
a body to which the containers and the syringe are mountable;
dual port means for providing first, second and third gas and
liquid ports into the interiors of the first, second and third
containers;
a first passageway fluidly connecting the first and second liquid
ports to permit fluid flow from the first container to the second
container but not flow in the reverse direction;
first means for pumping the first liquid pharmaceutical into the
second container through the first and second liquid ports along
the first passageway so the pumped first pharmaceutical mixes with
the second pharmaceutical in the second container to create a first
mixed liquid pharmaceutical while gasses pass into the first
container and out of the second container through the first and
second gas ports, respectively;
second means for pumping the first mixed liquid pharmaceutical from
the second container through the second liquid port and the third,
liquid pharmaceutical from the third container through the third
liquid port while replacing the first mixed and third
pharmaceuticals with gasses which pass into the second and third
containers through the second and third gas ports; and
means for fluidly directing the first mixed and third
pharmaceuticals from the second and third liquid ports to the
needle cannula;
whereby the mixed and third pharmaceuticals are pumped from the
second and third containers by the second and third pumping means,
through the needle cannula and into the syringe.
20. The dispenser of claim 19 further comprising means for visually
indicating the amount of the mixed and third pharmaceuticals pumped
into the syringe.
21. The dispenser of claim 19 wherein the first and second pumping
means include means for preventing the pumping of liquid from the
second container into the first or third containers and for
preventing the pumping of liquid from the third container into the
first or second containers.
22. The dispenser of claim 19 wherein the fluidly directing means
includes supplemental check valves which permit fluid flow from the
second and third liquid ports to the needle cannula but prevents
fluid flow from the needle cannula to the second and third liquid
ports.
Description
BACKGROUND OF THE INVENTION
Therapeutic insulin is of three basic types: fast-acting,
intermediate-acting and long-acting. Insulin users often use a
combination of two types of insulin depending on the user's blood
sugar level, the time of day, nourishment intake and expected
activity. For example, insulin injected at the beginning of an
active day may have more of the fast-acting insulin, while the
insulin injection given at the end of the day before going to bed
would likely have more intermediate or long-acting insulin.
One of the problems with conventional insulin syringes is that they
are designed to inject only one type of insulin, not a combination.
Although insulin can be obtained as a mixture of the two types, the
mixtures are generally a preset combination, such as 70%
intermediate-acting and 30% fast-acting. Thus, the prior art limits
the insulin user to a set mixture of the two insulins or the need
to make two separate injections.
Another problem relates to pharmaceuticals which are kept in a
lyophilized (dried) condition until use; they are then mixed with a
diluent to reconstitute the pharmaceutical. This is conventionally
done by syringe transfer.
SUMMARY OF THE INVENTION
The present invention is directed to a medication dispenser which
can be used with one or more conventional medication containing
containers, such as vials or cartridges, to supply a conventional
syringe with a desired amount of the one or more medications. This
permits the user to deliver medication, such as insulin, in desired
amounts and proportions of each from a single, typically
conventional, syringe. The dispenser also permits reconstituting a
lyophilized pharmaceutical by mixing two or more pharmaceutical
components prior to supplying the syringe with the medication.
The medication dispenser is typically used to directly fill a
syringe with measured amounts of one or more liquid medications.
The dispenser includes a body which has a number of cavities which
are used to hold or position two or more liquid medication
containers, typically vials or cartridges, and a syringe. The vials
and cartridges are of the type having a septum at one end. The
septum of each vial is pierced by a pair of hollow spikes. One of
the spikes, the liquid spike, is used to allow the liquid
medication to flow out of the vial while the other spike, the gas
spike, is used to introduce air into the vial to replace the liquid
medication drawn from the vial. With cartridge, the liquid spike
pierces the septum while the gas spike pierces an elastomeric
piston at the other end of the cartridge. Measured amounts of the
liquid medication are pumped out of each vial while air
simultaneously replaces the liquid pumped out of the vial. The
replacement can be either passive, in which the act of pumping
liquid medication through the liquid spike causes air to be pulled
into the vial, or active, by which air is pumped into the vial at
the same rate as liquid is pumped out of the vial.
The present invention finds particular utility for use in
dispensing two different types of insulin into a syringe; this use
is described with reference to the preferred embodiments. However,
the invention could be used with a single medication as well. For
example, human growth hormone is very expensive and requires
accurate doses. With the present invention, two vials of human
growth hormone could be mounted to the dispenser; when one vial is
completely drained, the other vial could be used to keep from
wasting the last bit of the growth hormone in the one vial. Also,
the invention could be carried out using a dispenser usable with
one medication container or three or more medication containers. In
addition, one or more of the containers could contain a lyophilized
pharmaceutical and another a diluent. The two could be connected so
the user could reconstitute the lyophilized pharmaceutical just
prior to use.
The liquid can be pumped using different types of pumps. One pump
type is a reciprocating piston and cylinder type pump. With the
reciprocating pump, the piston is reciprocated within the cylinder
a desired number of times according to how much medicine is to be
driven into the syringe. The dispenser is constructed to prevent
the reverse flow of liquid into the pharmaceutical containers. For
example, with a reciprocating pump-type of dispenser, check valves
can be used. Other types of dispensers, such as one using a
peristaltic pump, can prevent reverse flow through the construction
of the pump itself. The invention permits insulin users the freedom
to quickly and easily select the proportions of insulin to be
injected depending upon the user's current needs.
One of the primary advantages of the invention is that it is
designed to be used with conventional syringes and conventional
medication-containing cartridges and vials. Each of the disclosed
embodiments of the invention permits the user to select the amount
of one or more medications to be dispensed into a syringe through
the syringe's needle cannula. The invention provides flexibility
and ease of use with a relatively inexpensive dispenser.
With the present invention, the inside of the vial remains at
essentially atmospheric pressure. The gas used to replace the
liquid drawn out of the vial is typically air; however, other gases
such as nitrogen could be used as well.
The needle cannula typically provides a relatively narrow
restriction for the passage of the liquid medication. The present
invention recognizes that this restriction exists and accommodates
it through the construction of the fluid path between the pump and
the needle cannula. With the peristaltic pump version, the hollow
tubes which couple the peristaltic pump to the common fluid chamber
adjacent the needle cannula are constructed so that they can expand
or bulge to accommodate intermittently high flow rates by providing
a resilient reservoir or chamber leading into the needle cannula.
With the reciprocating pump embodiment, the flow path is partially
defined by a resilient surface which can be deformed when under
pressure thus enlarging the volume of the flow path to accommodate
the sudden increase in the volume of liquid medication from the
reciprocating pump.
Other features and advantages of the invention will appear from the
following description in which the preferred embodiments have been
set forth in detail in conjunction with the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a reciprocating pump embodiment of
a multiple medication dispenser made according to the invention
with first and second vials and a syringe shown in phantom
lines;
FIG. 2 is an exploded isometric view of the dispenser of FIG.
1;
FIG. 3 is a cross-sectional view taken along line 3--3 of FIG. 1
but omitting the body and the support base;
FIG. 4 shows the structure of FIG. 3 just prior to mounting a vial,
to which an adaptor ring has been mounted, into the split ring
guide;
FIG. 5 illustrates the structure of FIG. 4 with the spikes fully
penetrating the septum of the vial but prior to any axial movement
of the piston within the cylinder;
FIG. 6 illustrates the structure of FIG. 5, after the delivery
stroke during which the piston moved to the delivery position, and
illustrating the flow of fluid from the bore of the cylinder, along
the flow path and to the needle cannula;
FIG. 7 illustrates the structure of FIG. 6 at the end of a
replenish stroke, with the piston having moved to the replenish
position, and the flow of fluid from the vial into the base of the
cylinder as suggested by the arrows;
FIG. 8 is an enlarged top view of the manifold base of FIG. 2;
FIG. 9 is a cross-sectional view of the manifold base of FIG. 8
taken along line 9--9, the groove in the support surface of the
manifold base being shown deeper than it is for purposes of
illustration;
FIG. 10 illustrates in somewhat an exaggerated form the operation
of the supplemental check valve formed by the tapered cup of the
resilient manifold element and the externally tapered conical
extension of the manifold cover;
FIG. 11 is a perspective view of an alternative embodiment of the
dispenser of FIG. 1 using a rotary peristaltic-type pump
mechanism;
FIG. 12 is an exploded isometric view of the dispenser of FIG. 11
shown in conjunction with a pair of vials and a syringe in phantom
lines;
FIG. 13 is a partial cross-sectional view of the dispenser of FIG.
12 showing the pumping action of the peristaltic pump;
FIG. 13A is a simplified partial cross-sectional view of the
dispenser of FIG. 12 showing the interlock mechanism which prevents
the dials from being turned without a vial in place;
FIG. 14 is an enlarged cross-sectional view of a portion of the
dispenser of FIG. 11 illustrating the air intake and the septum
pierceable by the needle cannula of the syringe;
FIG. 15 is a perspective view of an alternative embodiment of the
reciprocating pump multiple medication dispenser of FIG. 1
incorporating the ability to mix, and typically reconstitute, two
pharmaceutical components prior to delivery of the mixed
pharmaceutical into the syringe alone or in conjunction with
another pharmaceutical;
FIG. 16 is an exploded isometric view of the dispenser of FIG.
15;
FIG. 17 is a cross-sectional view of the dispenser of FIG. 15 shown
in the pre-use, as-delivered condition with a first cartridge
containing a diluent, a second cartridge containing a lyophilized
pharmaceutical component and a third cartridge containing a liquid
pharmaceutical;
FIG. 18 shows the dispenser of FIG. 17 at the end of a delivery
stroke, following several delivery strokes from the condition of
FIG. 17, of the first cartridge thus driving the diluent from the
cartridge into the second cartridge where the diluent mixes with
and reconstitutes the lyophilized pharmaceutical component;
FIG. 18A is an enlarged view of a portion of the dispenser of FIG.
18 illustrating the fluid flow from the interior or bore of the
cylinder associated with the first cartridge, along a passageway
connecting the cylinders associated with the first and second
cartridges, past a check valve positioned along a passageway, past
a flapper valve element, through the liquid spike and into the
second cartridge;
FIG. 19 illustrates the dispenser of FIG. 18 at the end of a
replenish stroke of the first cartridge;
FIG. 19A illustrates an enlarged view of a portion of the dispenser
of FIG. 19 illustrating the flow of liquid from the first
cartridge, through the liquid spike, past the flapper valve element
and into the interior of the cylinder associated with the first
cartridge;
FIG. 20 is a transverse cross-sectional view of FIG. 15 showing a
user swabbing a septum through an access opening in the body prior
to piercing the septum with needle cannula of a syringe; and
FIG. 21 shows an alternative embodiment of the invention in a view
similar to that of FIG. 20 in which the user lifts a spring-biased
cover, which normally covers the access opening, while swabbing the
septum.
DESCRIPTION OF THE PREFERRED EMBODIMENT
FIGS. 1 and 2 illustrate a first reciprocating pump type multiple
medication dispenser for use with first and second vials 4, 6 and a
syringe 8. The following description will discuss first vial 4 and
the various components associated therewith recognizing that
similar components will be present and used with second vial 6 but
not described independently; this is clearly illustrated in FIG. 2.
Vial 4 is of the type having a pierceable septum, not shown, held
in place by a band 10 at the access end 12 of vial 4. A segmented
adaptor ring 14 is mounted to vial 4 at access end 12 for the
reasons described below. By the use of adaptor ring 14, different
types and configurations of vials 4 can be used with only the need
to change adaptor ring 14.
Dispenser 2 also includes a body 16 having vial guide bores 18 and
a syringe guide bore 20. Body 16 rests on, but is freely removable
from, a support base 22 as shown in FIG. 1.
FIG. 3 illustrates the structure of FIG. 1 as viewed along line 3-3
but with body 16 and support base 22 not illustrated. Dispenser 2
includes a pair of cup-shaped split guide rings 24 each having a
central opening 26 at the base 28 of guide ring 24. Opening 26 is
sized to fit snugly around a cylinder 30 extending upwardly as a
one piece extension from a manifold cover 32. Adaptor ring 14, body
16, split guide ring 24, cylinder 30 and manifold cover 32 are all
typically made of a hard plastic, such as polycarbonate. Split
guide ring 24 is secured to manifold cover 32 using an adhesive, by
ultrasonic welding or by other appropriate techniques.
A disk-like spike support 34 is movably mounted within each split
guide ring 24. Spike support 34 has an annular ledge 36 which
presses against a lug 38 extending inwardly from the inner wall 40
of split guide ring 24 by the force of a coil compression spring
42, typically made of spring-quality stainless steel. As suggested
in FIGS. 4 and 5, movement of vial 4 together with adaptor ring 14
in the direction of arrow 44 causes ring 14 to engage camming
surface 46 extending from the inside of resilient arm 48 in the
direction of arrow 50. Doing so permits spike support 34 to
disengage from an upwardly facing ledge 52 formed on the inside of
arm 48 below surface 46. This permits spike support 34 to move
downwardly, in the direction of arrow 44, as discussed below.
Spike support 34 includes a pair of hollow, pointed spikes 54, 56
which are positioned to pierce the septum of vial 4 when the vial
is mounted within split guide ring 24 as shown in FIGS. 4 and 5.
Spikes 54 and 56 are both preferably of stainless steel. Spike 54
extends through a central bore within spike support 34 and through
a cylindrical extension 58 of spike support 34. A combination
piston/flapper valve 60, made of silicone rubber, is mounted to
extension 58 and over the outer end 62 of liquid spike 54.
Combination 60 includes a piston 64 sized to engage the cylinder
wall 66 of cylinder 30. Combination 60 also includes a flapper
valve element 68 which is hinged to piston 64 at position 70. The
end of element 68 opposite position 70, indicated by reference
numeral 72, touches cylinder wall 66 so that as piston 64 moves
downwardly with respect to FIG. 3, element 68 is forced upwardly
against the outer end 62 of liquid spike 54 thus sealing the liquid
spike. When piston 30 moves in the opposite direction, that is
upwardly with reference to FIG. 3, end 72 of element 68 also drags
along wall 66 to move away from outer end 62 thus uncovering the
outer end and permitting fluid communication between the interior
74 of vial 4 and interior or bore 76 of cylinder 30, which is
defined by cylinder wall 66.
Dispenser 2 also includes a manifold assembly 78. Manifold assembly
78 includes generally manifold cover 32, a resilient manifold
element 80 and a manifold base 82. Resilient manifold element 80 is
preferably made of silicone rubber while manifold base 82 is made
of polycarbonate. Manifold assembly 78 defines a flow path
extending from interior 76 of cylinder 30 to a needle cannula
chamber 84 adjacent a needle cannula septum 86. Septum 86 is held
in place by a threaded cap 87. Referring primarily to FIG. 3,
interior 76 connects to a passageway 88 which passes through an
externally conical element 90. Element 90 fits within an internally
conically tapered cup-shaped extension 92 of resilient manifold
element 80. As seen in FIGS. 8 and 9, manifold base 82 has a
T-shaped groove 94 formed in its support surface 96. One end 98 of
groove 94 is positioned beneath needle cannula chamber 84 while the
other two ends 100, 102 are positioned below vials 4, 6. In the
preferred embodiment, each arm of manifold base 82 is about 10 mm
wide while groove 94 is about 0.25 mm deep and about 3 mm wide. The
depth of groove 94 in the various figures has been exaggerated for
purposes of illustration. The passage of the liquid medicine along
the flow path will now be described with reference to FIGS. 6, 7
and 10.
FIG. 6 shows the structure of FIG. 5 after the vial has been moved
in the direction of arrow 44 from the replenish position of FIGS. 5
and 7 to the delivery position of FIG. 6 during a delivery stroke.
During the delivery stroke illustrated in FIG. 6, the fluid,
typically the liquid medication from within interior 74 of vial 4,
is rather suddenly pressurized by the movement of piston 64. The
sudden movement of liquid is resisted by the thin needle cannula
108. To accommodate the flow restriction created by having the
liquid pass into syringe 8 through needle cannula 108, the flow
path is configured to be resiliently expandable when subjected to
pressurized fluid. This increased volume of the flow path is
graphically illustrated when one compares FIGS. 6 and 7. During the
delivery stroke, fluid in interior 76 is forced from interior 76 by
the movement of piston 64 in the direction of arrow 44 causing the
fluid to move along passageway 88. This pressurized fluid causes
resilient manifold element 80 to bow downwardly, as suggested in
exaggerated form in FIG. 10, into groove 94 and also causes
cup-shaped extension 92 to bow outwardly permitting the fluid to
move in the direction of the arrows of FIGS. 6 and 10. The fluid
pressure also causes the remainder of resilient manifold element 80
to be deflected into groove 94, as can be seen by comparing FIGS. 5
and 6, so that the fluid moves along the flow path between the
resilient surface 104 of element 80 and a bottom surface 106 of
manifold cover 32. Thus, the region between surfaces 104, 106 along
the flow path expands to accommodate the pressurization of the
fluid caused by the delivery stroke.
FIG. 7 illustrates the replenish stroke during which the liquid
medicine from the interior 74 of vial 4 is used to replace or
replenish that which had been forced out of interior 76 of cylinder
30 during the delivery stroke. During movement of vial 4 in the
direction of arrow 110, a low pressure region is formed in interior
76. This causes the supplemental valve created by conical element
90 and cup-shaped extension 92 to close. The movement of piston 64
in the direction of arrow 110 also causes end 72 of flapper valve
element 68 to drag along cylinder wall 66 thus unsealing end 62 of
liquid spike 54 to permit the flow of liquid medicine from interior
74, through liquid spike 54 and into interior 76 as suggested in
FIG. 7. To permit this to occur, air spike 56 permits air to freely
flow into interior 74 to replace the liquid pharmaceutical passing
through liquid spike 54. Thus, interior 74 remains at atmospheric
pressure at all times.
FIGS. 11 and 12 illustrate an alternative embodiment of the
invention which utilizes a peristaltic pump instead the reciprocal,
piston and cylinder type of pump used with the embodiment of FIG.
1. Dispenser 120 includes a body 122 having cavities 124, 126 and
128 sized to accept vials 130, 132 and syringe 134. A lid 136 is
mountable over cavities 124, 126 so to cover vials 130, 132.
Dispenser 120 also includes a spike assembly 138 having two pairs
of liquid and air spikes 140, 142, one pair for each of vials 130,
132. Dispenser 120 also includes a peristaltic pump assembly 144
secured to body 122 and resting on a base 146.
Pump assembly 144 includes a pump body 148 defining a pair of
generally circular recesses 150. Flexible liquid and gas tubes 152,
154 are connected to liquid and gas spikes 140, 142 at their one
ends and are positioned along the accurate inner surfaces 156, 158
which bound recess 150. The other ends of tubes 152, 154 terminate
at T-connections 160, 162, shown in FIG. 14. Liquid T-connection
160 connects to a fitting 164 extending from an L-shaped element
166 defining a needle cannula chamber 168 bounded by a needle
septum 170. Needle septum 170 is held in place by a threaded cap
172. Air T-connection 162 has an air filter 174 mounted at its end
and secured in place by an air filter cap 176.
Four peristaltic rollers 178 are rotatably mounted to the inner
surface 180 of a manually rotatable dial 182 by a number of screws
184. Dials 182 are held in place by knobs 186 which are fastened to
the ends of an axle 188 by screws 190; screws 190 are threaded into
complementary threaded holes at the ends of the axle. Axle 188
passes through holes 192 in dials 182 and also through a center
bore 194 formed in body 148. There is sufficient frictional drag
among axle 188, bore 194, knobs 186 and screws 190 so that rotation
of dials 182 will not cause knobs 186 to rotate as well. Knobs 186
have zero indicators 196 which are oriented with dose indicator
indicia 198, typically the zero indicia, at the beginning of use.
As shown in FIG. 13, rotation of dials 182 in the direction of
arrow 200 will cause rollers 178 to rotate about axle 188 and also
about the screws 184 securing them to dial 182. This causes air to
be forced into vial 130 and liquid to be forced out of vial 130 at
the same rate so that the interior of the vial remains at
atmospheric pressure. Using peristaltic pumps eliminates the need
for check valves.
It is preferred that dials 182 move in only one direction. To
facilitate this a ratchet mechanism is used. For example, a series
of ramped depressions (not shown) can be formed in surface 180.
These depressions are engaged by a pin 204 having one end housed
within a bore 206 formed in body 148 and the other end pressing
against surface 180 in position to engage the ramped depressions.
Pins 204 are biased toward surfaces 180 by a common spring 208
housed within bore 206. Other anti-reverse mechanisms can be used
as well.
Split ring adaptors 214, see FIGS. 12 and 13A, are mounted over the
ends of vials 130, 132. Ringer adaptors 214 operate to actuate
interlock arms 216 when vials 130, 132 are fully within bores 124,
126 as in FIGS. 3 and 3A. Arms 216 are biased to the solid line
position of FIG. 13A by a bent spring 218 so that the outer ends
220 of arms 216 engage grooves 222 formed in the outside of dials
182. When vials 130, 132 are in the positions of FIGS. 13, 13A,
upstanding ends 224 of arms 216 are pushed downwardly to the dashed
line position of FIG. 13A which lifts ends 220 out from groove .222
against the bias of spring 218. This prevents the rotation of dial
182 in the direction of arrow 226 unless a vial 130, 132 together
with a proper adaptor ring 214 is fully mounted within body
122.
To operate dispenser 120, vials 130, 132 are placed into cavities
124, 126 so that their septums are pierced by spikes 140, 142. Lid
136 is then used to cover cavities 124, 126 and syringe 134 is
mounted into syringe cavity 128 until the syringe's needle cannula
210 pierces septum 170. Knobs 186 are then rotated until the
respective zero indicators 196 are aligned with zero dose indicia
198. Dials 182 are then rotated an appropriate amount according to
the amount and proportion of each pharmaceutical. After the
appropriate amount and proportion of the pharmaceuticals are pumped
into syringe 134, the syringe is removed and the injection can be
given.
In both embodiments there will be an initial amount of
pharmaceutical which must be pumped from the vials along the flow
path before any pharmaceutical is forced into the syringe. Thus, an
initiation procedure must be followed to purge the air from the
flow path. One way to do this is to force one or a combination of
the liquid pharmaceuticals from the vials along the flow path. Once
the liquid pharmaceutical begins to enter the syringe, the syringe
could be withdrawn from the dispenser, the pharmaceutical expulsed
from the syringe and the syringe reinserted into the dispenser.
Subsequent pump actuation would cause accurate metering of the
pharmaceuticals into the syringe. Alternatively, a bleed valve
could be used adjacent the needle cannula septum to allow the air
within the flow path to be expulsed. To ensure the proper
proportion of the liquid pharmaceuticals are present in the flow
path after the initialization, specialized procedures may be used.
For example, if the desired mixture is equal parts of two
pharmaceuticals, with the embodiment of FIG. 1 both vials 4, 6
could be pressed down, somewhat slowly, at the same time so that
the fluid mixture within the flow path will be about equal parts of
both liquid pharmaceuticals. In some cases the volume of liquid
within the flow path is small enough not to matter insofar as
proportions are concerned. Thus, any specialized procedures which
may be used will depend upon the particular pharmaceuticals
involved, the volume of the flow path and the need to have precise
proportions. For example, a small variation in the proportions
between two different types of insulin may not be significant.
FIGS. 15-20 are directed to an alternative embodiment of dispenser
2 of FIG. 1. Dispenser 2a is similar to dispenser 2 but can
accommodate three medication containers in the form of cartridges
as opposed to two vial type medication containers in the embodiment
of FIG. 1. Also, dispenser 2a is constructed so that first
cartridge 230 contains a diluent 231, second cartridge 232 contains
a pharmaceutical component, in the preferred embodiment lyophilized
pharmaceutical 233, while the third cartridge 234 contains a liquid
pharmaceutical 235.
Many of the components of dispensers 2, 2a are the same or related
and have similar referencing numerals. Those aspects of dispenser
2a that are different from dispenser 2 are discussed below.
Body 16a has first, second and third cartridge guide bores 18a,
18b, 18c and a syringe guide bore 20a sized to fully contain the
cartridges 230, 232, 234 and partially contained syringe 8. Body
16a has a pair of cutouts 236 adjacent bores 18b, 18c to permit the
user visual access to the interiors of second and third cartridges
232, 234. The cutouts have clear sliders 238 which ride within
cutouts 236. Sliders 238 can move within cutouts 236 but are snug
enough within the cutout that once placed in position, the slider
will stay in position until repositioned by the user. As shown best
in FIG. 15, sliders 238 have a series of dose markings 240
including a zero marking 242. As will be discussed in more detail
below, the amount of pharmaceutical within first or third
cartridges 230, 234 which is forced into syringe 8 can be
determined by first aligning zero marking 242 with a meniscus of
the liquid pharmaceutical within container and then both counting
the number of pump cycles and viewing the movement of the meniscus
within cartridges 232, 234 along markings 240.
Body 16a also includes a clear window 244 to allow the user to see
the amount of diluent 231 within first cartridge 230. A syringe
cutout 245 is formed along syringe guide bore 20a to allow the user
visual access to the amount of medication forced into syringe
8.
Prior to use dispenser 2a comes in the configuration of FIG. 15 but
without cartridges 230, 232, 234 mounted therein. Dispenser 2a
includes three gas spike assemblies 246. Each gas spike assembly
246 includes a generally cylindrical body 248 having a hollow,
enlarged upper end 250. Gas spike 56a has its outer end exposed and
its inner end positioned within the interior 252 of enlarged upper
end 250 of spike assembly 246. Interior 252 is filled with a loose
air filter material, such as cotton. Air flows into interior 252
through a set of air ports 254 extending around the periphery of
enlarged upper end 250.
To mount cartridges 230, 232, 234 within bodies 16a, gas spike
assemblies 246 are removed from cartridge guide bores 18a, 18b, 18c
and cartridges 230, 232, 234 are mounted to the gas spike
assemblies 246 by inserting gas spikes 56a through the pierceable,
elastomeric piston 256 of each of cartridges 230, 232, 234. The
combined cartridge/gas spike assembly is then mounted within the
appropriate cartridge guide bore 18a, 18b, 18c. Septum 86 is
cleaned using a swab 258 inserted through an access port 260 formed
in body 16a as shown in FIG. 20.
Upon mounting the cartridge/gas spike assembly combination into
body 16a, the septum ends 262 of the cartridges pass over liquid
spikes 54a as the liquid spikes pass through the septums of the
cartridges. At this point the interiors of the cartridges have two
spikes, liquid spike 54a and gas spike 56a opening into the
interior of the cartridges. Reciprocal movement of spike assembly
246 mounted to third cartridge 234 during its delivery and return
strokes, which are down and up in the figures, causes
pharmaceutical 235 to flow from the interior of cartridge 234, into
bore 76c, past cup-shaped extension 92 between resilient manifold
element 80a and manifold cover 32a, into needle cannula chamber
84a, through needle cannula 108 and into syringe 8. This occurs in
the same basic manner for fluid flow from cartridge 232 into the
syringe 8 and for the embodiment of FIGS. 1-10.
The main distinction between the two embodiments of FIGS. 1-10 and
15-20 relates to the ability of dispenser 2a to transfer the
contents of cartridge 230 into cartridge 232, thus mixing with the
contents of cartridge 232, before driving the mixture into syringe
8. Manifold cover 32a, as shown best in FIGS. 18A and 19A, defines
a passageway 266 between bore 76a and bore 76b. A check valve 268
is positioned along passageway 266 to permit fluid to flow from
bore 76a into bore 76b but not in the reverse direction. Thus,
during a delivery stroke of cartridge 230, diluent 231 passes from
bore 76a, through passageway 266, past check valve 268 and into
bore 76b. At this point the diluent can either pass up through
liquid spike 54a entering into second cartridge 232 or deflect
resilient manifold 80a downwardly thus forcing cup-shaped element
92 away from conical element 90. However, the flow of the liquid
diluent is substantially unrestricted past flapper valve element
68, through liquid spike 54a and into second cartridge 232 so that
is the direction of travel of the diluent.
As can be seen in FIG. 19A, during the replenish stroke of first
cartridge 230, that is when the first cartridge moves upwardly in
the direction in arrow 270, diluent 231 goes into bore 76a thus
replenishing the supply of the diluent in the bore as combination
piston/flapper valve 60 moves upwardly. However, during this stroke
check valve 268 remains closed so that liquid downstream of check
valve 268 does not get pulled back into bore 76a. Once diluent 231
has been transferred into second cartridge 232 to form a mixed
pharmaceutical 272, second cartridge 232 can be actuated or pumped
to drive the mixed pharmaceutical from the second cartridge into
syringe 8. Backflow into first cartridge 230 during this process is
prevented by check valve 268.
This third embodiment has been described with reference to a
diluent 231 and a lyophilized pharmaceutical component 233 which
are combined and mixed to form a mixed pharmaceutical 272. However,
lyophilized pharmaceutical component 233 could be replaced by a
liquid pharmaceutical component. Diluent 231 could be replaced by a
clinically active liquid pharmaceutical component. Accordingly, as
used in this application, a pharmaceutical component can be an
active component, such as a diluent 231, a lyophilized
pharmaceutical component or a liquid pharmaceutical. A diluent can
be mixed with a lyophilized, or other non-liquid, pharmaceutical or
a liquid pharmaceutical. Likewise, both first and second cartridges
230, 232 could contain two clinically active pharmaceutical
components.
FIG. 21 illustrates an alternative embodiment of the invention in
which access ports 260 are normally sealed by a two-sided cover
274. Cover 274 is biased to its closed (dashed-line) position by a
pair of springs 276. Springs 276 are captured within openings 278
formed in body 16a in the region of the syringe cut-outs 245 of
dispenser 2a. Therefore, septum 86 is exposed through ports 260 for
cleaning.
Other modifications and variations can be made to the disclosed
embodiments without departing from the subject of the invention as
defined in the following claims. For example, the invention can be
carried out using one or more than three pharmaceutical containers.
Also, the same medication can be used in more than one of the
containers. Gas spikes 56a could be used to pierce the septums of
the cartridges in a manner similar to that used in the FIG. 1-10
embodiment. Receptacles other than a syringe, such as a needless
injector or an IV bags could be used to accept the pharmaceuticals
from the cartridge or vials. In such a case, a fluid connection
other than a needle cannula 108 piercing a septum 86 could be
used.
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